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Diss Factsheets

Administrative data

Description of key information

The test substance (EC: 433-100-1) caused no sensitisation potential in the guinea-pig maximisation test.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-01-11 to 1999-02-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted 17 July, 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Directive 96/54
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
No LLNA study was conducted as an in vivo study according to OCED 406 was conducted in 1999, before the first version of the LLNA (OECD 429) was issued in 2002.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: approx. 4-5 weeks
- Weight at study initiation: 300 - 312 g
- Housing: in groups in Terluran - cages on Altromin saw fiber bedding. Max. group size 10 animals
- Diet: ad libitum, Altromin 3122 maintenance diet for guinea pigs, rich in crude fiber, totaily-pathogen-free-TPF
- Water: ad libitum, tap water


ENVIRONMENTAL CONDITIONS
- Temperature: 22 ±3° C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30
Route:
intradermal and epicutaneous
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
Intra-dermal Induction: 0.1 mL of 50 % (v/v) test item homogenised in Oleum helianthi;
Dermal induction: 2 g test item moistened with CMC 1 %
Day(s)/duration:
epicutaneous: 48 h
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Concentration / amount:
2 g of the test Item and moistened with CMC 1%
Day(s)/duration:
24 h
Adequacy of challenge:
not specified
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- INTRADERMAL INJECTION:
Three pairs of intradermal injections of 0.1 mL volume were given in the shoulder region which was cleared of hair so that one of each pair lies on each side of the midline.
Test group: Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: Prepared test item (2000 mg in 8 ml NaCl 0,9%)
Injection 3: Prepared test item at a concentration of 50% (V/V) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline

Control group : Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: NaCl 0.9%
Injection 3: NaCl 0.9% at a concentration of 50%> (V/V) in Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injections 1 and 2 were given close to each other and nearest to the head, while 3 is given toward the caudal part of the test area.

- Topical Application:
Test and Control Group: Day 6
Approximately twenty-four hours before the topical induction application the test area, after close clipping was painted with 0.5 ml of 10%> sodium lauryl sulfate in vaseline, in order to create a local Irritation.
Test Group Day 7
A patch was fully loaded with the test item (2 g), moistened with CMC 1 %, applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control Group: Day 7
A patch was fully loaded with the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.

B. CHALLENGE EXPOSURE
Test and Control Group : Day 20
A patch loaded with 2 g of the test Item and moistened with CMC 1% was applied to the left flank of the animals and, a patch loaded with the vehicle to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing for 24 hours. At the end of the challenge skin was cleaned with the aid of moistened gauze patches.
Challenge controls:
yes, for details refer to "details on study design"
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: no positive control conducted
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance (EC: 433-100-1) caused no sensitisation potential in the guinea-pig maximisation test.
Executive summary:

The test substance (EC: 433-100-1) was tested for skin sensitising properties in a guinea pig maximisation test according to EU method B.6 and OECD guideline 406. During the induction phase the guinea pigs (10 test group, 5 control group all females, strain: Hsd Poc:DH) were intradermally injected with a suspension of the test substance and, after treatment with sodium lauryl sulfate topically treated with 100 % test substance. After a latency of 14 days - to allow a potential reaction of the immune system - the animals were challenged with the test item on the flank. The sensitization rate after application of the test substance was 0 %. Under the test conditions described below the test item showed no sensitizing properties. No other signs of toxicity were observed. All animals showed normal food intake and weight gain. It was concluded that under the conditions of the present test, the test substance has no sensitisation potential in the guinea-pig maximisation test.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test substance (EC: 433-100-1) was tested for skin sensitising properties in a guinea pig maximisation test according to EU method B.6 and OECD guideline 406. During the induction phase the guinea pigs (10 test group, 5 control group all females, strain: Hsd Poc:DH) were intradermally injected with a suspension of the test substance and, after treatment with sodium lauryl sulfate, topically treated with 100 % test substance. After a latency of 14 days - to allow a potential reaction of the immune system - the animals were challenged with the test item on the flank. The sensitization rate after application of the test substance was 0 %. Under the test conditions described below the test item showed no sensitizing properties. No other signs of toxicity were observed. All animals showed normal food intake and weight gain. It was concluded that under the conditions of the present test, the test substance has no sensitisation potential in the guinea-pig maximisation test.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) No 2019/521.